Head of Clinical Quality Assurance (Newark)

Head of Clinical Quality Assurance

About the Company

Globally renowned biopharmaceutical company

Industry

Pharmaceuticals

Type

Privately Held

About the Role

The Company is seeking a Clinical Quality Director to lead all GxP audits and inspections at the US Affiliate. The successful candidate will be responsible for preparing and executing individual and larger project audit plans, as well as developing and maintaining the GCP audit strategy. This role involves conducting internal, CRO, and site audits, and clearly communicating and reporting audit outcomes. The Clinical Quality Director will also support inspection readiness activities, participate in the development and improvement of the Quality Management System, and handle deviations, quality issues, CAPAs, and changes in clinical studies. Additionally, the role includes providing GCP and other relevant training, representing QA in study teams, and maintaining expert knowledge of GCP legislation and guidelines.

Applicants for the Clinical Quality Director position at the company should have a college degree in a relevant field, with a preference for life sciences, and a graduate degree is a plus. A minimum of 10 years' experience in quality auditor roles with significant exposure to GCP / GLP is required. The ideal candidate will have a proven track record of leading people, managing multiple projects, and developing positive relationships. Strong analytical, strategic, and planning skills are essential, as is the ability to create efficient processes and have a high level of attention to detail. The role demands a reliable, dependable, and consistent worker with excellent interpersonal and communication skills, who is also enthusiastic, ethical, and loyal to the organization's vision and goals.

Hiring Manager Title

CEO

Travel Percent

Less than 10%

Functions

• Medical Care / Hospital Administration